NCT05576935 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

De Pauw K, Roelands B, Cheung SS, de Geus B, Rietjens G, Meeusen R
Guidelines to classify subject groups in sport-science research. Int J Sports Physiol Perform. 2013 Mar;8(2):111-22. Review.
Hernandez R, Roll SC, Jin H, Schneider S, Pyatak EA
Validation of the National Aeronautics and Space Administration Task Load Index (NASA-TLX) adapted for the whole day repeated measures context. Ergonomics. 2022 Jul;65(7):960-975. doi: 10.1080/00140139.2021.2006317. Epub 2021 Nov 22.
Kaida K, Takahashi M, Akerstedt T, Nakata A, Otsuka Y, Haratani T, Fukasawa K
Validation of the Karolinska sleepiness scale against performance and EEG variables. Clin Neurophysiol. 2006 Jul;117(7):1574-81. Epub 2006 May 6.
Lee KA, Hicks G, Nino-Murcia G
Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8.

The Individual Response of Healthy Individuals to Mental Fatigue: a Randomized Crossover Trial Investigating the Influence of Internal Factors in the Effects of Mental Fatigue on Human Performance

Details for clinical trial NCT05576935

Clinical trial NCT05576935 - References